EPA ICR No. 2488.01; Attachment I May 29, 2013

Attachment I: Page 1 Specific Changes Made to the Forms & Order Templates for EDSP/FIFRA Orders

The forms and order templates used for EDSP/FIFRA Orders are currently approved under
OMB Control No. 2070

- 0176 (EPA ICR No. 2249) and were used for EDSP Tier 1 Orders issued to Pesticide Registrants and Manufacturers/Importers of Pesticide Inerts identifi ed on List 1. In adopting those same forms for List 2 Chemicals, EPA identified and has made the following changes to those forms and order templates. Once approved, EPA will use the
modified forms for all EDSP/FIFRA Orders issued to Pesticide Registrants and Manufacturers/Importers of Pesticide Inerts.

1. Revisions to the Order Template Used for PAIs

Previous Title: FFDCA 408(p) Order Template for Pesticide Registrants ( As of September 16, 2009)

. 1

Changed Title: FIFRA/FFDCA §408(p) Order Template for Pesticide Active Ingredients (As of April 15, 2013)

. 2

Added language on the first page in the “Summary Information” section to include EPA contact information that will be populated by the electronic order issuance system: EPA Contact: EPA Contact Phone Number: EPA Contact E

- Mail Address: This language was added due to the removal of the static EPA contact information from the last page of the order template under Section IX “ Additional Information .”

A mend ed language under Section V.A. “ Format for Submissions” to reflect revised electronic delivery of recipient responses . The new language reads: “The Agency requires Order Recipients to submit completed study profiles, supporting data, and all related correspondence request electronically using the EPA’s Central Data Exchange (CDX), the point of entry on the Environmental Information Exchange Network (Exchange Network) for environmental submissions to the Agency.”

A mend ed language under Section V.A. “ Format for Submissions” change in the instructions for formatting and submission of the required data. ( Subsequent to the release of the initial EDSP Screening Orders t he Office of Pesticide Programs revised their information sheet that was referenced previously .) The new langu age reads:

“ In addition, Pesticide Registration (PR) Notice **2011**

**- 3 Standard Format for Data**  **Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA)** 

. This PR Notice discusses both the recommended and the required procedures for submitting FIFRA and FFDCA data http://www.epa.gov/PR_Notices/pr2011

- 3.pdf. ”

A mended language under Section V.D. “ Delivery Instructions ” for electronic delivery of recipient responses

. The new language reads:

1 See Attachment C(1) to the Renewal ICR (EPA ICR No. 2249.03; OMB Control No. 2070

- 0176).

2 See Attachment C(1) to this ICR.EPA ICR No. 2488.01; Attachment I May 29, 2013

Attachment I: Page 2 “Your response to this Order and all related correspondence must be submitted electronically to the EPA using the following methods:
i. Submissions must be sent electronically to EPA via CDX.
ii. Access the EDSP electronic report ing tool and instructions on the EPA EDSP Internet homepage at http://www.epa.gov/endo and follow the appropriate links.”

Deleted the word “written” through the order template to reflect the movement towards
electronic submissions

.

2. Revisions to the Order Template Used for P esticide Inert Ingredients

Previous Title: FFDCA 408(p) Order Template for Pesticide Inert Ingredients (As of September 16, 2009). 3

Changed Title: FIFRA/FFDCA §408(p) Order Template for Pesticide Inert Ingredients (As of April 15, 2013). 4

Added language on the first page in the “Summary Information ” section to include EPA contact information that will be filled by the electronic order issuance system:
EPA Contact:
EPA Contact Phone Number:
EPA Contact E

- Mail Address: This language was added due to the removal of the static EPA contact information from the last page of the order template under Section IX “ Additional Information

. ”

A mend ed language under Section V.A. “ Format for Submissions ” to reflect revised electronic delivery of recipient responses. The new language reads: “The Agency requires Order Recipients to submit completed study profiles, supporting data, and all related correspondence request electronically using the EPA’s Central Data Exchange (CDX), the poi nt of entry on the Environmental Information Exchange Network (Exchange Network) for environmental submissions to the Agency.”

A mend ed language under Section V.A. “ Format for Submissions” change in the instructions for the formatting and submission of the required data. (Subsequent to the release of the initial EDSP Screening Orders the Office of Pesticide Programs revised their information sheet that was referenced previously.) The new la nguage reads:

“ In addition, Pesticide Registration (PR) Notice **2011**

**- 3 Standard Format for Data**  **Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA)** 

. This PR Notice discusses both the recommended and the required procedures for submitting FIFRA and FFDCA data http://www.epa.gov/PR_Notices/pr2011

- 3.pdf. ”

3 See Attachment C( 2 ) to the Renewal IC R (EPA ICR No. 2249.03; OMB Control No. 2070

- 0176).

4 See Attachment C( 2 ) to this ICR.EPA ICR No. 2488.01; Attachment I May 29, 2013

Attachment I: Page 3 A mended language under Section V.D. “ Delivery Instructions ” for electronic delivery of recipient responses . The new language reads: “Your response to this Order and all related correspondence must be submitted electronically to the EPA using the following methods:

i. Submissions must be sent electronically to EPA via CDX.

ii. Access the EDSP electronic repo rting tool and instructions on the EPA EDSP Internet homepage at http://www.epa.gov/endo and follow the appropriate links.”

Deleted the word “written” through the order template to reflect the movement towards

electronic submissions.

3. Revisions to the Init ial Response Form Used for Individual Order Recipients

Previous Title: EPA Form No. 6300

- 05, entitled "FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call

- In (DCI)

- Initial Response Form for Individual Order Recipients ” (As of April 3, 2009)

. 5

Changed Title: EPA Form No. 6300

- 05, entitled "FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call

- In (DCI)

- Initial Response Form for Individual Order Recipients” (As of March 27

, 20 13 ). 6

In Part 2.1 of the form, response options B and C were combined. Option D was re

- lettered to Option C. The form was also modified in Part 2.1 by revising the “response” columns to reflect this change.

In Part 4 of the form, language was revised to reflect the move ment to electronic submission of the form. The new language reads:

“ Your response to this Order and all related correspondence must be submitted electronically to the EPA using the following methods:

• Submissions must be sent electronically to EPA via CDX.

• Access the EDSP electronic reporting tool and instruction on the EPA EDSP Internet homepage at http://www.epa.gov/endo and follow the appropriate links to CDX.”

4. Revisions to the Initial Response Form Used for a Consortium/ Task Force

Previous Title : EPA Form No. 6300

- 05

- C, entitled "FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call

- In (DCI)

- Initial Response Form for Consortium/ Task Force" (As of April 3, 2009)

. 7

Changed Title: EPA Form No. 6300

- 05

- C, entitled "FFDCA §408(p) Order/FIFRA §( 3)(c)(2)(B) Data Call

- In (DCI)

- Initial Response Form for Consortium/ Task Force" (As of March 27

, 20 13 ). 8

5 See Attachment D ( 1 ) to the Renewal ICR (EPA ICR No. 2249.03; OMB Control No. 2070

- 0176).

6 See Attachment D(1 ) to this ICR.

7 See Attachment D (2) to the Renewal ICR (EPA ICR No. 2249.03; OMB Control No. 2070

- 0176).

8 See Attachment D (2) to this ICR.EPA ICR No. 2488.01; Attachment I May 29, 2013

Attachment I: Page 4 In Part 5 of the form , language was revised to reflect the movement to electronic submission of the form. The new language reads:

“ Your response t o this Order and all related correspondence must be submitted electronically to the EPA using the following methods:

• Submissions must be sent electronically to EPA via CDX.

• Access the EDSP electronic reporting tool and instruction on the EPA EDSP Int ernet homepage at http://www.epa.gov/endo and follow the appropriate links to CDX.”